Phase II
Eurofins CDMO (Contract Development & Manufacturing Organization) will help you set the stage for the commercial process in Phase II of your drug development program.
Validated processes for 7 API products
Our development team works closely with clients to provide phase-appropriate solutions to balance their immediate and long-term API development needs.
Our Capabilities Include:
- Route or step rebuild
- Process optimization & demonstration
- Impurities assessment & synthesis
- Full structure characterization & elucidation
- Analytical method development & qualification
- Stress studies & ICH stability standards
- CMC gap analysis for commercialization
- Drug Substance process development with analytical support (Small Molecules / Biologics)
- Drug Product formulation and process development with analytical support (Small Molecules / Biologics)
- Sterile and Non Sterile Manufacturing with analytical support
- Clinical Packaging and Logistics
